Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M0045665

FDA device recall Z-1072-2009 · posted 2009-04-09 · Terminated

Recall details

Recalling firm

Boston Scientific Corp

Reason for recall

The marker band may detach from the sheath and a clinical failure could result in an embolism.

Action taken

The firm initiated the recall on December 24, 2009 and notified consignees via "Urgent Company Initiated Medical Device Recall - Immediate Action Required" letters which explain the reason for the recall and request the affected product be returned to the Boston Scientific Corporation Distribution Center. An amendment letter with two additional Convoy Advanced Delivery Sheath Kit models (M0045748ST0 and M0045749ST0) was sent to affected customers on January 27, 2009. Direct questions about this recall to your local Sales Representative.

Root cause

Process design

Status

Terminated

Product code

DYB

Quantity affected

31,340 of all units

Distribution

Worldwide Distribution.

Date initiated

2008-12-24

Date posted

2009-04-09

Date terminated

2010-04-06

Location

San Jose, CA

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